Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Undesirable effects are more common during the first months after start of intake of Primolut preparations, and subside with duration of treatment. The frequencies are based on reporting rates from postmarketing experience and literature.



System           Very     Common    Uncommon       Rare         Very rare     Frequency Organ Class      common
≥ 1/100    ≥ 1/1,000        ≥         < 1/10,000    not known
≥ 1/10        to          to      1/10,000
< 1/10      < 1/100         to
< 1/1000

Immune                                             Hyper- system                                             sensitivity disorders                                          reactions

Nervous                   Headache    Migraine                                  Dizziness system disorders

Psychiatric                                                                     Depression disorders                                                                       aggravated 
Eye disorders                                                    Visual disturbances

Respiratory,                                                     Dyspnoea thoracic and mediastinal disorders

Gastro-                   Nausea                                                Abdomin intestinal                                                                      al pain disorders

Hepato-biliary                                                                  Cholestasis disorders
Jaundice

Skin and                                           Urticaria subcutaneous tissue



System                 Very          Common       Uncommon        Rare           Very rare    Frequency Organ Class            common
≥ 1/100       ≥ 1/1,000         ≥          < 1/10,000    not known ≥ 1/10             to             to       1/10,000
< 1/10         < 1/100          to
< 1/1000
 disorders                                                         Rash 
Reproductive       Uterine/          Amenorrhoea* system and         Vaginal breast             bleeding disorders          including
Spotting*

Hypo- menorrhoea*
General                              Oedema disorders and administration site conditions

* in the indication Endometriosis

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il